Mycophenolic Acid Tablet, Delayed Release
FDA Recall NDC 67877-427
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Mycophenolic Acid (NDC 67877-427). A significant event, classified as Class II, was initiated on Sep 03, 2024 by Ascend Laboratories, Llc. The reported reason for this action was: "Failed Dissolution Specifications"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications
Sep 03, 2024
Oct 02, 2024
117,493 bottles
Recall Profile & Regulatory Data
Event ID
95275
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and PR
Product Description
Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.
Batch or Lot Expiration Information
Lot# Lots 22123437, 22123438, 22123535, Exp Date 9/30/24; 22123536, 22123537, 22123538, 22123646, 22123647, Exp Date 10/31/24; 23120529, 23120530, Exp Date 1/31/25; 23120703, 23120705, Exp Date 2/28/25; 23121429, 23121726, 23122049, 23122097, Exp Date, 4/30/25; 23121984, 23121985, 23121986, Exp Date 5/31/25; 23122325, 23122329, 23122330, 23122331, Exp Date 6/30/26; 23122776, 23122852, 23122853, 23123154, 23123155, Exp Date 8/31/26; 23123458, Exp Date 9/30/26.
Affected Packages Involved in this Recall
67877-426-12Product
67877-426-05Product
67877-426-33Product
67877-426-38Product
67877-427-12Product
67877-427-05Product
67877-427-33Product
67877-427-38Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
